CYPROHEPTADINE HYDROCHLORIDE | A208938 | ZYDUS PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Appco Pharma LLC FDA-2026-P-8559 Appco Pharma LLC filed a suitability petition with the FDA requesting a determination of whether diethylpropion is suitable for inclusion in an abbreviated new drug application for a controlled-release formulation. The petitioner seeks confirmation that the agency would accept an ANDA for diethylpro | Suitability | 2026-08-04 | Open | Appco Pharma LLC |
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-6811 Senores Pharmaceuticals, Inc. filed a petition requesting FDA determination that their proposed drug product is suitable for abbreviated new drug application (ANDA) review, which involves establishing bioequivalence to a reference product and seeking approval to market a generic version through the | Suitability | 2026-06-16 | Open | Senores Pharmaceuticals, Inc. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5978 Hyman, Phelps & McNamara, P.C. filed a suitability petition requesting that the FDA determine the regulatory suitability of a proposed product or manufacturing process, though the specific drug name and requested action are not detailed in the provided document excerpt. | Suitability | 2026-05-27 | Open | Hyman, Phelps & McNamara, P.C. |
Amendment to Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1278 Senores Pharmaceuticals, Inc. filed an amendment to an ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to develop Cyproheptadine Hydrochloride orally disintegrating tablets in 2 mg and 4 mg strengths, based on the reference lis | Suitability | 2025-12-09 | Granted | Senores Pharmaceuticals, Inc. |
Amendment to Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1278 Senores Pharmaceuticals, Inc. filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Cyproheptadine Hydrochloride Orally Disintegrating Tablets in 2 mg and 4 mg strengths suitable for submission as an ANDA, with a reference li | Suitability | 2025-06-11 | Granted | Senores Pharmaceuticals, Inc. |
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1278 Senores Pharmaceuticals, Inc. filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Cyproheptadine Hydrochloride Orally Disintegrating Tablets in 2 mg and 4 mg strengths suitable for submission as an ANDA, with the reference | Suitability | 2025-05-16 | Granted | Senores Pharmaceuticals, Inc. |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-4601 Pharmobedient Consulting, LLC filed a suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Cyproheptadine Hydrochloride Tablets in 2 mg strength, which differs from the Reference Li | Suitability | 2024-10-01 | Granted | Pharmobedient Consulting, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0685
per ea
Lowest NADAC/Unit
$0.0685
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 70710111000CYPROHEPTADINE 4 MG TABLET | $0.0685 | EA | Generic | — | 2026-10-21 |
| 70710111001CYPROHEPTADINE 4 MG TABLET | $0.0685 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.